EN 13976-2-2011 en Rescue systems - Transportation of incubators - Part 2 System requirements (Remains Current)《运输的孵化器 第2部分 系统需求》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 13976-2:2011Rescue systems Transportation of incubatorsPart 2: System requirementsBS EN 13976-2:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implem

2、entation of EN 13976-2:2011.It supersedes BS EN 13976-2:2003 which is withdrawn.BSI, as a member of CEN, is obliged to publish BS EN 13976-2 as aBritish Standard. However, attention is drawn to the fact that theUK committee voted against its approval as a European standard.This negative vote was the

3、 result of a new requirement introducedin subclause 4.7 (EMC) of the final draft, which now states thatEquipment used during air transportation shall comply with RTCADO 160.RTCA DO 160 describes a series of test methods for theenvironmental testing of avionics hardware. Whereas equipmentcan be teste

4、d in accordance with RTCA DO 160, it does notcontain any requirements itself, and therefore it is not possible formanufacturers to comply with RTCA DO 160.The UK participation in its preparation was entrusted to TechnicalCommittee CH/239, Rescue systems.A list of organizations represented on this co

5、mmittee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 68337 4ICS 11.040.10; 11.160Compliance with a British Standard cannot confer immunity fr

6、omlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2011.Amendments issued since publicationDate Text affectedBS EN 13976-2:2011EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13976-2 May 2011 ICS 11.040.10; 11.160

7、 Supersedes EN 13976-2:2003English Version Rescue systems - Transportation of incubators - Part 2: System requirements Systmes de sauvetage - Transport dincubateurs - Partie 2: Exigences relatives au systme Rettungssysteme - Inkubatortransport - Teil 2: Anforderungen an Transportsysteme This Europea

8、n Standard was approved by CEN on 14 April 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concer

9、ning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into

10、 its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Irelan

11、d, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17,

12、 B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13976-2:2011: EBS EN 13976-2:2011EN 13976-2:2011 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .64 Genera

13、l requirements 64.1 System combination 64.2 Suspension/noise/comfort (shock-absorption) 64.3 Temperature conditions 64.4 Ingress of liquids .64.5 Vibration .64.6 Mechanical integrity 64.7 EMC .74.8 Mass 74.9 Electricity 74.10 Fixation of component parts 74.11 Modifications 7Annex A (informative) Erg

14、onomics .8A.1 Space 8A.2 Loading .8Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .9Bibliography . 10BS EN 13976-2:2011EN 13976-2:2011 (E) 3 Foreword This document (EN 13976-2:2011) has been prepared by T

15、echnical Committee CEN/TC 239 “Rescue systems”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2011, and conflicting national standards shall be

16、withdrawn at the latest by November 2011. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 13976-2:2003. Th

17、is document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. EN 13976

18、-2:2003 has been technically revised. The following points represent the most important changes in the revision: 1) clarified ambiguous and unclear issues between the two parts (requirements for the transport incubator system interface conditions and system requirements, respectively); 2) proposed i

19、tems in order to improve fixation, interchangeability and interoperability of the transport incubator system when transported in hospitals and between hospitals using different ambulances and air crafts; 3) adapted the standard to developments in neonatal intensive care; 4) excluded proposals on sta

20、ndards for stretchers, vehicles or medical devices. EN 13976 consists of the following parts, under the general title: Rescue systems Transportation of incubators: Part 1: Interface conditions Part 2: System requirements. According to the CEN/CENELEC Internal Regulations, the national standards orga

21、nizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Po

22、rtugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 13976-2:2011EN 13976-2:2011 (E) 4 Introduction This European Standard gives the requirements for a transport incubator system that will ensure its interchangeability as well as its safe and effective functi

23、on in different vehicles or crafts. Such systems are essential in allowing the uninterrupted care of patients. Requirements for interface conditions are given in part 1 (EN 13976-1). BS EN 13976-2:2011EN 13976-2:2011 (E) 5 1 Scope This European Standard specifies the requirements for a transport inc

24、ubator system needed for care and treatment of infants, used in emergency or planned transport. It specifies the particular requirements needed to ensure the proper function of equipment during transportation (e.g. monitors, respirators, infusion pumps, extra corporeal lung support- (ECLS-) systems,

25、 gas supply) and to provide safe transportation for infants and operators. This European Standard also stipulates that the equipment or systems shall not interfere with the functions of the ambulance providing transportation. This European Standard does not give requirements for the vehicles, crafts

26、, devices or incubators as such, these requirements are found in other standards. However, transport incubators are normally combined with other equipment to form a “transport incubator system”. 2 Normative references The following referenced documents are indispensable for the application of this d

27、ocument. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 1789, Medical vehicles and their equipment Road ambulances EN 1865 (all parts), Patient handling equipment used in road ambulanc

28、es EN 13718-1, Medical vehicles and their equipment Air ambulances Part 1: Requirements for medical devices used in air ambulances EN 13718-2, Medical vehicles and their equipment Air ambulances Part 2: Operational and technical requirements of air ambulances EN 13976-1:2011, Rescue systems Transpor

29、tation of incubators Part 1: Interface conditions EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005) EN 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance C

30、ollateral standard: Electromagnetic compatibility Requirements and tests (IEC 60601-1-2:2007, modified) EN 60601-2-20, Medical electrical equipment Part 2-20: Particular requirements for basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009) RTCA DO 160, Radio Te

31、chnical Commission for Aeronautics Environmental conditions and test procedures for airborne equipment (corresponding to EUROCAE ed-14) publication available at the RTCA Secretariat, Suite 500, 1425 K Street, N.W. Washington DC, 20005, USA RTCA DO 199, Radio Technical Commission for Aeronautics Pote

32、ntial interference to aircraft electronic equipment from devices carried on board publication available at the RTCA Secretariat, Suite 500, 1425 K Street, N.W. Washington DC, 20005, USA BS EN 13976-2:2011EN 13976-2:2011 (E) 6 3 Terms and definitions For the purposes of this document, the terms and d

33、efinitions given in EN 13976-1:2011 apply. 4 General requirements 4.1 System combination Requirements for interfaces are found in part 1 of this standard (EN 13976-1) and basic requirements for transport incubators are described in EN 60601-2-20. Any medical device which is part of the transport inc

34、ubator system shall be designed for use with neonates and infants and for use in transport settings. All of the equipment that is integrated or part of the system shall be tested according to the existing standards relevant to the type of vehicle in which it is to be used. Equipment employed as part

35、 of transport incubator system shall be specified by the manufacturer as having an intended use in transportation by road and air ambulances and labelled according to the standard. NOTE Basic requirements for vehicles used as ambulances and medical devices in these vehicles are described in EN 1789

36、for road ambulances, in EN 13718-1 and EN 13718-2 for air ambulances and in EN 1865 for stretchers. 4.2 Suspension/noise/comfort (shock-absorption) Ear defenders for the infants shall be used during all transports. Noise from additional equipment shall not exceed 60 dB(A) as set by EN 60601-2-20. NO

37、TE Vibration and noise can interfere with the general comfort and well-being of infants. Therefore the vibration to which they are exposed should be as low as possible. The transportation of the baby should be at an appropriate speed to ensure the comfort of the baby. High speeds are rarely necessar

38、y. 4.3 Temperature conditions 4.3.1 The transport incubator system shall comply with the relevant requirements of EN 60601-2-20 as a minimum standard with regard to controlling the internal temperature. 4.3.2 Where the transport incubator system is to be used at extremes of temperature, additional t

39、est data shall be supplied in the accompanying documents. These should include, where relevant, information about operation during exposure up to + 40 C for 15 min and 30 C for 15 min. The effect of wind chill at intermediate temperatures should be considered. 4.4 Ingress of liquids All equipment fo

40、rming part of the transport incubator system shall be drip-proof according to EN 60601-2-20. If the equipment complies with this standard only with an additional accessory or procedure, the manufacturer shall describe in the accompanying documents how to comply with this standard. 4.5 Vibration All

41、equipment forming part of the transport incubator system shall comply with EN 1789 or EN 13718-1 and EN 13718-2. 4.6 Mechanical integrity All equipment forming part of the transport incubator system shall comply with EN 60601-1. BS EN 13976-2:2011EN 13976-2:2011 (E) 7 EN 60601-2-20 applies for trans

42、port incubators. The free fall test in EN 1789 applies (i.e. 0,75 m) for hand-held equipment. 4.7 EMC All equipment forming part of the transport incubator system shall comply with EN 60601-1-2 and EN 60601-2-20. Equipment used during air transportation shall comply with RTCA DO 160. For equipment u

43、sed for transportation, each user shall carry out mutual compatibility assessments when required to ensure that all medical equipment functions correctly in each mode of transport and with every type of equipment for communication and/or navigation to be used during the transport. NOTE The manufactu

44、rer should include the requirement for mutual compatibility assessments in the instructions for use. 4.8 Mass The mass of the transport incubator system including its rail parts shall not exceed 140 kg. The requirement for stretchers defined in EN 1865 is 150 kg minimum loading capacity, a margin of

45、 10 kg for the interface is used. The TIS shall be marked with its weight. NOTE 1 This clause does not apply for cases where the trolley is an integral part of the TIS. NOTE 2 In all cases the mass should be as low as possible. In cases where the TIS has to be transported in air ambulances more rest

46、rictive weight limits may apply. 4.9 Electricity The transport incubator system shall be capable of operating on 12 V DC, 24 V DC or, 24VDC and 230 V AC/50 Hz power supplies during transport. The electrical system shall be designed to prevent the vehicle from draining electrical power from the trans

47、port incubator system or its interface equipment. 4.10 Fixation of component parts All component parts of the transport incubator system shall be securely fixed in road ambulances in conformity with EN 1789 and test criteria for the vehicle used or for aircraft as specified by the aviation authoriti

48、es in accordance with EN 13718-1. 4.11 Modifications Where a transport incubator system is modified by someone other than the original manufacturer of the transport incubator system, the modifier shall confirm that any additional device is appropriately secured (according to EN 1789, EN 60601-1) and

49、 that the fixation of the transport incubator system to the vehicle can still safely carry the extra load (EN 1789 and EN 13718-1 and EN 13718-2). BS EN 13976-2:2011EN 13976-2:2011 (E) 8 Annex A (informative) Ergonomics A.1 Space A.1.1 In all vehicles used for incubator transport e.g. road ambulances, air ambulances, helicopters, the transport incubator system should be placed so that the attending medical staff can monitor and care for the infant, the monitors, and the pumps, and easily per